Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)

Corify Care

Status: Enrolling

Conditions: Cardiac Arrhythmia

Treatments: Device: ACORYS MAPPING SYSTEM

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05772182

SAVE-COR

Details and patient eligibility

About

Noninvasive evaluation of the electrical status of the heart is based on the standard ECG but remains suboptimal due to difficulties with arrhythmia characterization and location. Electrocardiographic Imaging (ECGI) provides maps of cardiac electrical excitation in relation to the anatomy of the heart using an extensive number of electrodes from the body surface. The applicant will develop a systematic evaluation of the ECGI as a tool to detect cardiac regions of interest in cardiac arrhythmias.

Full description

The specific aim of this multicenter observational study is to evaluate the precision of non-invasive cardiac mapping system ECGI using multipolar intracardiac recordings as the gold standard. We will develop a non-invasive ECGi and intracardiac recordings in patients undergoing electrophysiology studies and/or intracardiac devices implantation to correlate the position of the regions of interest at predefined anatomy sites in patients with different organized arrhythmias. The long-term outcome of the electrophysiological characterization using ECGI will be also evaluated. Finally, the cost-efficiency of ECGI system as a support tool in cardiac arrhythmias diagnosis will be assessed.

Objectives: to perform a systematic evaluation of the ECGI with recordings using multipolar intracardiac recordings as the gold standard. Secondly, the study will also validate the ability of the ECGI recordings to increase the precision of the standard ECG interpretation by an expert.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for an invasive electroanatomic study and/or intracardiac device implantation.
• Having obtained and signed the informed consent for study participation.
• Ability to stand, to be able to obtain the 3D torso reconstruction necessary for the ECGI system.

Exclusion criteria

• <18 years old
• Inability to perform an endocardial catheterization and/or device implantation.
• Physical or mental disability to understand and accept the informed consent.
• Inability to stand to obtain the 3D torso reconstruction.
• active coronary ischemia or decompensated heart failure
• Intracardiac clot on trans-esophageal echocardiography
• Pregnancy.
• Disorganized arrhythmias (i.e. atrial fibrillation, polymorphic ventricular tachycardia).

Trial design

50 participants in 1 patient group

Groups/Cohorts

Description:

Patients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication

Treatment:

Device: ACORYS MAPPING SYSTEM